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BRIEF TITLE: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors


  • Org Study ID: 2018-01
  • Secondary ID:
  • NCT ID: NCT03662204
  • NCT Alias:
  • Sponsor: Exact Sciences Corporation - Industry
  • Source: Exact Sciences Corporation

Brief Summary

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Detailed Description


Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with
any solid tumor. Subjects will have a blood sample collected at enrollment and provide
medical history prior to initiation of treatment. There will be no further follow-up.

Overal Status Start Date Phase Study Type
Recruiting August 23, 2018 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Biomarker Evaluation

Primary Outcome 1 - Time Frame: Point in time (one day) blood collection at enrollment

Condition:

  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Uterine Cancer
  • Kidney Cancer
  • Renal Pelvis Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Stomach Cancer
  • Ovarian Cancer
  • Esophageal Cancer

Eligibility

Criteria:
Inclusion Criteria:

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate,
bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or<br/> esophageal cancer.

OR

Subject has suspicion of a primary malignancy of bladder, kidney/renal pelvis, or
ovarian cancer based on imaging.

3. Subject understands the study procedures and is able to provide informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.

Exclusion Criteria:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal
cell or squamous cell skin cancers).

2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample
collection.

3. Any treatment for the primary malignancy or sites of metastases. Subject may not have
started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or
other treatment and/or surgery prior to blood sample collection.

4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood
collection.

5. Less than 7 days between biopsy (other than FNA) of target pathology and blood
collection.

6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

7. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Alexandra Massoud

Phone: 608-957-5652

Email: amassoud@exactsciences.com

Locations

Facility Status Contact
Arizona Clinical Research Center, Inc.
Tucson, Arizona 85715
United States
Recruiting Patricia Plezia
520-290-2510
mmodiano@acrcresearch.com
Urological Associates of Southern Arizona, PC
Tucson, Arizona 85741
United States
Recruiting Maria Smith

marias@uasapc.com
CARTI Cancer Center
Little Rock, Arkansas 72205
United States
Recruiting Carla Randall
501-906-3012
CRandall@CARTI.com
John Muir Clinical Research
Concord, California 94520
United States
Recruiting Suzanne Clements
925-674-2437
Suzanne.Clements@johnmuirhealth.com
Marin Cancer Care
Greenbrae, California 94904
United States
Recruiting Jamie Chang
415-925-5000
jchang@marincancercare.com
Alliance Research Centers
Laguna Hills, California 92653
United States
Recruiting Justin Deck
949-680-3490
jdeck@researchalliance.com
North County Oncology
Oceanside, California 92056
United States
Recruiting Yumiko Kawai
760-721-8597
ncoyumi@gmail.com
Adventist Health - Saint Helena Hospital
Saint Helena, California 94574
United States
Recruiting Shalese Canby
707-967-5831
canbysr@ah.org
Innovative Clinical Research Institute
Whittier, California 90603
United States
Recruiting Kirsten Bettino
562-693-4477
kbettino@airesearch.us
The Urology Center of Colorado
Denver, Colorado 80211
United States
Recruiting Chris Lightsey
303-762-7154
clightsey@tucc.com
Middlesex Hospital
Middletown, Connecticut 06457
United States
Recruiting Deborah Pantalena
860-358-2028
deborah.pantalena@midhosp.org
Easter Ct Hematology and Oncology
Norwich, Connecticut 06360
United States
Recruiting Jim Chaplin
860-886-8362
Jchamplin@echoct.com
Stamford Hospital
Stamford, Connecticut 06904
United States
Recruiting Ian Goff
203-276-8449
igoff@stamhealth.org
CSNF - Central Business Office
Jacksonville, Florida 32256
United States
Recruiting Jenni Bachhofer

Jenni.Bachhofer@CSNF.US
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United States
Recruiting Harish Gowda

harish@clorene.org
Piedmont Cancer Institute, PC
Atlanta, Georgia 30318
United States
Recruiting Derrick Carter
678-298-3238
dcarter@piedmontcancerinstitute.com
Lewis Hall Singletary Oncology Center
Thomasville, Georgia 31792
United States
Recruiting Tiffany Woolum

tfwoolum@archbold.org
PMG Research of DuPage Medical Group
Downers Grove, Illinois 60515
United States
Recruiting Peri Todd
630-545-7760
peri.todd@pmg-research.com
Presence Cancer Care / JOHA
Joliet, Illinois 60435
United States
Recruiting Karen Sceniak
815-730-3098
ksceniak@jolietoncology.com
Illinois CancerCare, P.C.
Peoria, Illinois 61615
United States
Recruiting Nancy Williams
309-243-3614
nwilliams@illinoiscancercare.com
Orchard Healthcare Reasearch Inc
Skokie, Illinois 60077
United States
Recruiting Joy Jardinico

jjardinico@orchardhr.com
PMG Research of McFarland Clinic
Ames, Iowa 50010
United States
Recruiting Erin Hackett
336-608-3500
St. Elizabeth's Edgewood Cancer Care Research
Edgewood, Kentucky 41017
United States
Recruiting Adrienne Snow
859-301-4735
john.losey@stelizabeth.com
Greater Baltimore Medical Center
Baltimore, Maryland 68506
United States
Recruiting Judy Bosley
443-849-3122
jbosley@gbmc.org
Holy Cross Hospital Resource Center Department of Cancer Research
Silver Spring, Maryland 20902
United States
Recruiting Lyudmila Kalnitskaya
301-754-7552
kalnitsl@holycrosshealth.org
Lowell General Hospital
Lowell, Massachusetts 01854
United States
Recruiting Clay Hardeman
978-788-6518
Clay.Hardeman@lowellgeneral.org
Park Nicollet Institute - Oncology Research
Saint Louis Park, Minnesota 55426
United States
Recruiting Janet Morgan

janet.morgan@parknicollet.com
Nebraska Hematology-Oncology -- Lincoln
Lincoln, Nebraska 68506
United States
Recruiting Kristina Benson
402-484-4908
kbenson@yourcancercare.com
Somnos Laboratories, Inc.
Lincoln, Nebraska 68510
United States
Recruiting Greg Rugh
402-486-3430
greg@somnos.com
Cancer Care Specialists
Reno, Nevada 89519
United States
Recruiting Amy Munoz
775-329-0222
amyy@ccsreno.com
Albany Medical College
Albany, New York 12208
United States
Recruiting Brenda Romeo
518-262-8579
AMCUrologyResearch@amc.edu
Brooklyn Urology Research Group
Brooklyn, New York 11201
United States
Recruiting Melanie Camacho

Mcamacho.burg@gmail.com
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York 12601
United States
Recruiting Lisa Crespi
845-437-5010
lcrespi@premiermedicalhv.com
Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division
Poughkeepsie, New York 12601
United States
Recruiting Alyson Cahill
845-451-7262
acahill@premiermedicalhv.com
Associated Medical Professionals
Syracuse, New York 13210
United States
Recruiting Sarah Faisal

SFaisal@ampofny.com
PMG Research of Hickory, LLC
Hickory, North Carolina 28601
United States
Recruiting Jennifer Lail

jlail@pmg-research.com
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina 28374
United States
Recruiting Pam Mason
910-715-4434
pmason@firsthealth.org
PMG Research of Rocky Mount
Rocky Mount, North Carolina 27804
United States
Recruiting Brandi Vincent
336-608-3500
brandi.vincent@pmg-research.com
PMG Research of Piedmont
Statesville, North Carolina 28625
United States
Recruiting Katherine Sanders

Katherine.Sanders@pmg-research.com
Marion L. Shepard Cancer Center
Washington, North Carolina 27889
United States
Recruiting Kristy Alligood
252-974-9389
Kristy.Alligood@VidantHealth.com
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma 73505
United States
Recruiting Susie McCoy
580-536-2121
susie.mccoy@ccswok.org
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United States
Recruiting Jessicca Rosario
484-526-7952
Jessicca.rosario@sluhn.org
Charleston Cancer Center
Charleston, South Carolina 29406
United States
Recruiting Ashley Moultrie
843-576-1024
AshleyA@CharlestonCancer.com
McLeod Center for Cancer Treatment and Research
Florence, South Carolina 29506
United States
Recruiting Dorie Sturgill
843-777-5929
peri.todd@pmg-research.com
Lowcountry Urology/PMG Research of Charleston, LLC
North Charleston, South Carolina 29406
United States
Recruiting Kathleen Walker

Kathleen.Walker@pmg-research.com
RH Clinical Research
Rapid City, South Dakota 57701
United States
Recruiting Angie Dunbar
605-755-2370
ADunbar@regionalhealth.org
PMG Research of Bristol, LLC
Bristol, Tennessee 37620
United States
Recruiting Amy Dye

adye@pmg-research.com
Sun Research Institute
San Antonio, Texas 78215
United States
Recruiting Beneta Parthiban
210-227-1289
bparthiban@sunresearch.com
Renovatio Clinical
The Woodlands, Texas 77380
United States
Recruiting Talal Kayyal
713-703-2398
talal.kayyal@renovatioclinical.com
Community Cancer Trials of Utah
Ogden, Utah 84405
United States
Recruiting Shirley Waters

admin@communitycancertrials.com
Urology of Virginia, PLLC
Virginia Beach, Virginia 23462
United States
Recruiting Donna DeVenuto
757-452-3453
DonnaSchriner@urologyofva.net
Seattle Urology Research Center
Burien, Washington 98166
United States
Recruiting Angel Felipe

surc@comcast.net
CAMC Clinical Trials Center
Charleston, West Virginia 25304
United States
Recruiting Christina Bethea
304-388-9679
Christina.bethea@camc.org
Mon Health Medical Center
Morgantown, West Virginia 26505
United States
Recruiting Karen Hunter
304-598-6581
hunterk@monhealthsys.org